Medical Device Compliance Manager
2 weeks ago
The Quality Systems Engineer II will support the CAPA process at Maple Grove, including nonconforming events, and ensure compliance to CAPA processes, Medical Device regulations, and BSC Quality System requirements.
Key Responsibilities- Mentoring cross-functional CAPA teams on root cause analysis, corrective action plans, and effectiveness verifications using project management best practices.
- Creating robust, compliant, and timely records using the electronic CAPA database system.
- Providing continuous and rigorous assessment of CAPA activities and review of documentation throughout the CAPA lifecycle.
- Bachelor's degree and 2+ years of experience in a medical device manufacturing setting within quality or regulatory/compliance environment.
- Knowledge of basic Quality System Requirements and Good Documentation Practices.
- Experience working with nonconforming material and/or CAPA methodologies/systems.
Boston Scientific offers a competitive salary, comprehensive benefits package, and opportunities for growth and development.
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Medical Device Product Development Specialist
2 weeks ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeAbout the RoleThe Medical Device Product Development Specialist will be responsible for ensuring the quality and safety of medical devices from concept to commercialization. This role involves working with cross-functional teams to develop test methods and equipment, and writing technical documentation to support the development process.Key...
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Medical Device Design Lead
6 days ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeJob DescriptionBoston Scientific is committed to advancing science for life by transforming lives through innovative medical solutions that improve patient lives. We are seeking a talented Medical Device Design Lead to join our team and contribute to the development of life-changing medical devices.Your Key Responsibilities:Design and develop mechanical...
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Senior Medical Device Engineer
1 week ago
Comuna Sănduleşti, Cluj, United States ATL Technology Full timeJob Title:Senior Medical Device EngineerCompany Overview:We are ATL Technology, a leading provider of custom engineered solutions for top medical device manufacturers. Our engineer-to-engineer approach enables us to develop custom interconnect solutions that improve the quality of life.Salary:$120,000 - $180,000 per year, depending on experienceJob...
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Medical Device Engineer III
2 weeks ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeBoston Scientific is a leading medical device company committed to advancing science for life. As a Medical Device Engineer III, you will play a critical role in our Interventional Cardiology division, designing and developing innovative medical devices that improve patient lives. With a strong focus on teamwork, decision-making, and technical leadership,...
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Director of Materials Compliance
2 weeks ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeAbout the RoleBoston Scientific seeks an experienced Senior Manager to lead a team of supplier quality engineers ensuring material supply compliance with Global Medical Device regulations.This involves leading cross-functional teams to onboard, maintain, and support material suppliers; investigating supplier-related material and service nonconformances;...
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Medical Device Software Engineer
2 weeks ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeAbout the Job: We are seeking a skilled R&D software engineer to join our ICTx R&D team at Boston Scientific. The successful candidate will participate in the design and development of medical device software and contribute to driving growth through efficient and effective development of new products.The ideal candidate will have experience in...
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Medical Device Development Specialist
2 weeks ago
Comuna Sănduleşti, Cluj, United States Atl Technology Full timeCompany OverviewAt Atl Technology, we pioneer a better way to bring medical devices to market. Our engineer-to-engineer approach enables the development of custom interconnect solutions that enhance the quality of life.
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Senior Medical Device Test Engineer
2 weeks ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeCompany OverviewBoston Scientific is a leading medical device manufacturer that has been advancing science for life for over 40 years. Our mission is to improve patient lives through innovative medical solutions.Job SummaryWe are seeking an experienced Quality Assurance Engineer II to join our team. As a Senior Medical Device Test Engineer, you will be...
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Medical Device Software Specialist
2 weeks ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeAbout UsBoston Scientific is a global leader in medical science, committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the...
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Quality Assurance Engineer for Medical Devices
1 month ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeAbout the RoleWe are seeking an experienced Design Quality Engineer III to join our team at Boston Scientific. As a key member of our cross-functional engineering teams, you will be responsible for representing design quality on value improvement projects (VIP) and identifying opportunities for cost savings.Your ResponsibilitiesAnalyze complaint and...
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Process Development Specialist
6 days ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeJob Description:Role Overview:Boston Scientific is a leading medical device company seeking an experienced Senior Process Development Engineer- Metals+ to join our team. This role involves working in a fast-paced, global environment to develop laser processes from concept to production. We are looking for a highly motivated engineer with strong leadership...
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Senior Engineer for Electrical Devices
3 weeks ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Corporation Full timeJob Title: Senior Engineer for Electrical DevicesAbout Boston Scientific:We are a global medical technology leader that shapes medical interventions. Our mission is to make a meaningful difference in patients' lives.Job Summary:We are seeking an experienced Senior Engineer for Electrical Devices to join our team. In this role, you will be responsible for...
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Device Development Technologist
2 weeks ago
Comuna Sănduleşti, Cluj, United States Anteris Technologies Ltd Full timeRequirementsBachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related field).Minimum of 2 years of experience in Process Development and Manufacturing Engineering within the medical device industry, preferably with Class III medical devices.The estimated salary range for this position is $90,000 - $110,000 per year, depending on...
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Senior Quality Assurance Manager
2 weeks ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeAbout the PositionAs a Senior Manager, you will lead a team of experienced supplier quality engineers to ensure compliance with Global Medical Device regulations. This involves onboarding, maintaining, and supporting material suppliers, investigating supplier-related nonconformances, and proactively engaging with suppliers to reduce risk and drive continuous...
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Senior Human Factors Engineer
2 weeks ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeCompany OverviewBoston Scientific is a leader in medical science, committed to solving the challenges that matter most. With a deep caring for human life, we aim to advance science for life and improve patient health.About the RoleWe are seeking an experienced Human Factors Engineer to apply HFE principles to products across the development lifecycle. As a...
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Contract Compliance Operations Specialist
6 days ago
Comuna Sănduleşti, Cluj, United States City Wide Facility Solutions Full timeJob Title: Contract Compliance Operations SpecialistCity Wide Facility Solutions is seeking a detail-oriented and organized Contract Compliance Operations Specialist to join our team. This role involves managing contract compliance for designated building maintenance services, establishing and maintaining effective relationships with independent contractors,...
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Medical Device Test Engineer
2 weeks ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeJob DescriptionDevelop test equipment to satisfy product requirements for design verification from concept to functional equipment.Write technical documentation for procedure execution, technical rationale, and evidence of the development process.Support development and coordinate the execution of Design Validation and Verification activities.
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Senior Supplier Development Manager
6 days ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeAbout the RoleA key aspect of this position is leading a team of supplier quality engineers to ensure material supply compliance with Global Medical Device regulations.This involves onboarding, maintaining, and supporting material suppliers; investigating supplier-related material and service nonconformances; engaging proactively with suppliers to reduce...
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Comuna Sănduleşti, Cluj, United States Anteris Technologies Ltd Full timeAt Anteris Technologies Ltd, we are pushing the boundaries of medical device development with a focus on structural heart solutions. As a Sr Design Assurance Quality Engineer, you will play a pivotal role in ensuring the quality and compliance of our products throughout their lifecycle.Key Responsibilities:Design Control & Compliance:Lead design assurance...
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Senior Systems Engineer
6 days ago
Comuna Sănduleşti, Cluj, United States Boston Scientific Full timeJoin Our TeamBoston Scientific is a global leader in medical technology, dedicated to advancing science for life. We're seeking a talented Systems Engineering Fellow to join our Cardiology team in Maple Grove, MN.About the OpportunityThis role offers the chance to work on cutting-edge medical device systems and collaborate with interdisciplinary teams. As a...